INSTITUTION / INVESTIGATOR-INITIATED CLINICAL TRIALS IN CANADA

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Jan Sedgeworth
Carexa Inc., Oakville, Canada

Lidia Derewlany
Ceruleus Inc. Toronto, Canada

Keywords

Regulations, clinical trials, Health Canada

Abstract

Institution/investigator-initiated clinical trials in Canada require adherence to similar regulations and processes required of large pharmaceutical manufacturers. This may require an investigator to file a Clinical Trial Application. This article outlines the responsibilities and actions that are required prior to, during, and after the conduct of an institution/investigator initiated trial.

Abstract 255 | PDF Downloads 264

References

1. Klein AV, Tomalin AM. Clinical trial applications in Canada. Can J Clin Pharmacol Vol 12(3) Fall 2005:e246-e250; Oct. 24, 2005.

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Published
Dec 08, 2018

Article Details

How to Cite
Sedgeworth, J., & Derewlany, L. (2018). INSTITUTION / INVESTIGATOR-INITIATED CLINICAL TRIALS IN CANADA. Journal of Population Therapeutics and Clinical Pharmacology, 13(2). http://www.jptcp.com/index.php/jptcp/article/view/122
Issue
Vol. 13 No. 2 (2006)
Section
Articles
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How to Cite

Sedgeworth, J., & Derewlany, L. (2018). INSTITUTION / INVESTIGATOR-INITIATED CLINICAL TRIALS IN CANADA. Journal of Population Therapeutics and Clinical Pharmacology, 13(2). http://www.jptcp.com/index.php/jptcp/article/view/122